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Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia

NCT02907333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2020-03-26

No results posted yet for this study

Summary

Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 6 months after the diagnosis with new examinations. The regression rate is based solely on the woman's own ability to clear the cervical lesions. The use of condoms has shown a relatively good protective effect against Human Papillomavirus (HPV) infection. It has furthermore been indicated that condoms increase the regression rate of cervical lesions.

The hypothesis of this study is that the regression rate of cervical intraepithelial neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up period of 6 months.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

BEHAVIORAL

Advice to use condoms

Sponsors & Collaborators

  • Hospital - and gynaecological out-patient clinics in Central Region Denmark

    collaborator UNKNOWN

  • Hospital - and gynaecological out-patient clinics in Region Zealand

    collaborator UNKNOWN

  • Research grant from Fonden for Faglig Udvikling af Speciallægepraksis

    collaborator UNKNOWN

  • Research grant from Kræftens Bekæmpelse

    collaborator UNKNOWN

  • Sponsorship for condoms from RFSU

    collaborator UNKNOWN

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Elsebeth Lynge, Professor · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02907333 on ClinicalTrials.gov